ISO 22716 requirements explained: video brief

Clauses that follow the product

ISO 22716 follows the flow of product through the plant rather than a management cycle. After the scope and terms in clauses 1 and 2, clauses 3 to 17 each open with a principle and describe good practice for that part of the operation. This short film walks through them.

Clause 3, personnel, asks for defined responsibilities, enough trained people, hygiene and health rules, and control of visitors and untrained personnel; in practice an organisation chart, GMP job descriptions, training records and hygiene rules that are followed. Clauses 4 and 5, premises and equipment, ask for facilities that protect the product: defined areas, flows that prevent mix-ups, cleanable surfaces, cleaning and sanitisation, maintenance, pest control and calibration where equipment measures, evidenced by a site plan with areas marked, cleaning and maintenance records, an equipment register, pest control reports and calibration certificates.

From materials to recalls and audit

The following clauses take the product onward: raw materials and packaging materials received, sampled, accepted and stored under control; production, from manufacturing to packaging, with batch documentation; finished products released, stored and shipped; and the quality control laboratory with its methods, samples and results. The practices then cover what happens when things go wrong: treatment of out-of-specification results, waste, subcontracting, deviations, complaints and recalls. Change control, internal audit and documentation complete the set.

The standard is written for manufacturers, fillers and contract manufacturers of cosmetic and personal-care products. ISO 22716:2007 is the only edition, confirmed by ISO in 2022. Certification is voluntary and decided by an independent certification body under its own scheme rules, and accreditation for this standard varies by body.

In the European Union, Regulation (EC) No 1223/2009 requires cosmetic products to be manufactured under good manufacturing practice and presumes compliance where manufacture follows EN ISO 22716:2007; certification itself is not mandatory. The standard covers production, control, storage and shipment, and excludes research and development, the distribution of finished products, worker safety and the environment. For contract manufacture, the certificate covers the site where the product is made, and a written agreement between contract giver and contract acceptor is expected.